R&D Quality Assurance Auditor

Role Summary

As an R&D Quality Assurance Auditor, you will be part of Elanco’s R&D Quality Assurance (ERDQA) organization, providing quality oversight and consultative support to Clinical Development and non-clinical research activities. In this role, you’ll be responsible for ensuring compliance with global regulatory requirements (GCP/GLP), supporting animal health registrations, and partnering closely with R&D teams and external partners to proactively drive quality and inspection readiness.

Responsibilities

• Plan, conduct, and report Quality oversight and audit activities for veterinary Good Clinical Practice (GCP) clinical studies and Good Laboratory Practice (GLP) non-clinical safety studies conducted internally and at third-party sites.
• Provide sponsor oversight for outsourced GLP studies, including protocol and final report reviews, and collaborate with study teams to ensure regulatory compliance.
• Issue audit reports, QA statements, and assess corrective and preventive actions (CAPAs), including independent follow-up to ensure effective resolution.
• Execute process audits (self-inspections) of internal R&D quality system processes and support preparation for regulatory authority inspections.
• Deliver quality and compliance training to R&D and Quality partners and serve as a trusted quality advisor to the R&D organization.

Qualifications

• Required: A minimum of 5-10 years of experience providing quality oversight or auditing of veterinary clinical and/or non-clinical safety studies regulated by FDA, EPA, USDA, or OECD.
• Required: Top Skills: Strong knowledge of GCP/GLP regulations and quality systems, combined with the ability to influence and partner effectively with senior scientific and business leaders.
• Preferred: Society for Quality Assurance (SQA) RQAP-GLP certification.
• Preferred: Experience supporting or participating in regulatory authority inspections.
• Preferred: Proven experience developing and delivering compliance training to diverse audiences.
• Preferred: Strong background in risk assessment and risk management tools.
• Preferred: Experience with IACUC, Biosafety Committee, and Health & Safety oversight activities.

Education

• Master’s degree in a life science (e.g., biology, animal science, pharmacy) with 5+ years of relevant experience, OR a Bachelor’s degree in a life science with 10+ years of relevant experience in the animal health industry.

Additional Requirements

• Travel: Up to 20% annually
• Location: Global Elanco Headquarters – Downtown Indianapolis, IN – Hybrid Work Environment